RTHawk, HeartVista Cardiac Package
K183274HeartVista, Inc. · cleared 2019-10-18 · product code LNH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“RTHawk is a software system designed from the ground up to provide a platform for efficient real-time MRI data acquisition, data transfer, image reconstruction, and interactive scan control and display of static and dynamic MR imaging data.”
source quote (p.6)
“RTHawk makes extensive use of spiral image acquisition techniques to maximize scan efficiency. While conventional scans acquire data line-by-line in a Cartesian grid, RTHawk collects data more efficiently in a spiral pattern. Spiral-pattern raw data must be reformatted for correct reconstruction and display, requiring additional computing resources and image correction procedures to reduce image artifacts and distortions, ensuring high-quality reconstructed images. The optional addition of L1-based denoising ("Compressed Sensing") to some Apps”
source quote (p.6)
“On-the-fly, sub-second latency adjustment of image acquisition parameters (e.g., scan plane, flip angle, field-of-view, etc.)”
source quote (p.10)
“New features intended to address cybersecurity concerns”
Validation studies (1)
Bench
sample size not stated
endpoints: SNR; uniformity
standards: IEC 60601-2-33 Ed 3.0 (2010-03), MS1-2008, MS3-2008, MS4-2010, MS8-2008, NEMA PS3.1 - 3.20 (2011), ISO 14971:2007, ES60601-1:2005/(R)2012 +A1 +C1+A2
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2026-04-14): "The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98779
- recall_reason_pattern
Software/algorithm-related recall in product code LNH (Philips North America, initiated 2025-12-03): "The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS)." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98111
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).